The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
NCT Number: NCT02983682
This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic pain in children. All participants will receive lidocaine infusion and severity of pain and degree of chronic-pain related disability will be assessed before and up to 4 weeks after infusion. Adverse events will be recorded.
Looking for future studies?
Notify Me8 year–18 year
All sexes
Interventional
Phase 3
Toronto, Ontario, M5G 1X8, Canada
Reports have shown that intravenous lidocaine infusions have been effective in relieving chronic pain that has been resistant to other therapies, with minimal side effects. The investigators would like to determine whether severity of pain and degree of chronic-pain related disability could be reduced with lidocaine infusion in children and to understand whether the dose of lidocaine correlates with blood levels in the same manner as it does in adults. The investigators will recruit 24 patients aged 8-18 with chronic pain that has not been relieved by standard therapies. Each patient will receive a lidocaine infusion over 2 hours. Blood will be drawn for lidocaine concentration before the beginning of the infusion, immediately after and 0.5, 2 and 4 hours after. Severity of pain and degree of disability will be recorded using a questionnaire measuring pain scores, sleep disruption, social disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks and then 4 weeks after. This study will help the investigators better understand the effectiveness and safety of intravenous lidocaine for chronic pain in children.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Withdrawal Criteria
Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.
Other names: Preservative Free Lidocaine Hydrochloride
Time frame: Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion
Pain scores will be measured using the Numeric Rating Scale
Time frame: Up to seven days prior to lidocaine infusion.
Participants will record all analgesics used in a pain diary provided by the investigators.
Time frame: Up to one month after lidocaine infusion
Participants will record all analgesics used in a pain diary provided by the investigators.
Time frame: intraoperative
Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache
Time frame: Day of the infusion, one week, two weeks and four weeks following the infusion.
The Adolescent Sleep Wake Scale will be used to assess quantity and quality of sleep.
Time frame: Day of the infusion, one week, two weeks and four weeks following infusion.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale will be used to measure how pain interferes with the participants activities of daily living
Time frame: Week prior to the infusion and at two and four weeks following the infusion.
Participants will record the number of hours of school attendance where relevant (e.g. no school holidays, no medical appointments).
The Hospital for Sick Children
Other
A Pilot Study of the Effectiveness of Lidocaine Infusions for the Management of Chronic Pain in Children
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03629197
Chronic Pain, Communication Research
Sacramento, California, United States
View Trial DetailsNCT05628246
Agnosia, Cancer Pain
Bangkoknoi, Bangkok, Thailand
View Trial DetailsNCT05572697
Chronic Pain, Dyssomnias
Rissa, Hasselvika, Norway
View Trial DetailsNCT06062108
Acute Pain, Chronic Pain
Draguignan, Var, France
View Trial Details